Written Answers Nos. 2124-2144
2124. Deputy Cathal Crowe asked the Minister for Health given the major treatment costs, when home dialysis and assisted dialysis will become available in each of the 96 HSE community health networks; and if she will make a statement on the matter. [74184/25]
View answerAs this is a service matter, it has been referred to the Health Service Executive for attention and direct reply to the Deputy.
2125. Deputy Cathal Crowe asked the Minister for Health whether the HIPE’s case mix system is tracking the cost of every dialysis session provided per in-patient stay; if not, if it is assigning an assumed cost per dialysis session per in-patient stay, thus underestimating the cost of kidney disease treatment; and if she will make a statement on the matter. [74185/25]
View answerAs this is a service matter I have asked the HSE to respond to the Deputy as soon as possible.
2126. Deputy Cathal Crowe asked the Minister for Health to provide a copy of the clinical guidelines for assessment and treatment of kidney patients who present in emergency departments; if this is in use in all hospitals; and if she will make a statement on the matter. [74187/25]
View answerAs this is a service matter I have asked the HSE to respond to the deputy as soon as possible.
2127. Deputy Cathal Crowe asked the Minister for Health given that a number of patients receiving dialysis are homeless or at risk of homelessness, if such patients will be automatically placed in the band 1 category in the future; and if she will make a statement on the matter. [74189/25]
View answerAs this refers to a service matter, regarding patients who are receiving dialysis who are homeless or at risk of homelessness, I have sent this question to the HSE for their response.
I also note that Band 1 eligibility for social housing is determined under housing legislation and local authority allocation schemes, which are the remit of the DHLGH and local authorities.
2128. Deputy Cathal Crowe asked the Minister for Health given the increasing frequency of storm related utility outages, the plans that are in place to protect vulnerable patients who are dependent on utilities for life saving treatments; and if she will make a statement on the matter. [74190/25]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
2129. Deputy Cathal Crowe asked the Minister for Health given that Donegal patients who were travelling to Northern Ireland or Beaumont hospital for treatment are now being sent to Galway, the reason treatment in Northern Ireland is no longer available, forcing patients to travel longer distances; whether accommodation costs for such patients will be covered given they could previously avail of free accommodation in a centre (details supplied); and if she will make a statement on the matter. [74191/25]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
2130. Deputy Cathal Crowe asked the Minister for Health if a reimbursement case has been made for the use of drugs (details supplied) in Ireland to the relevant authority; if so, the stage the drug approval is at; when a decision is likely to be taken on whether such drugs will or will not be reimbursed; whether supply of these drugs is currently being reimbursed by any Irish hospital; and if she will make a statement on the matter. [74192/25]
View answerUnder the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.
2131. Deputy Cormac Devlin asked the Minister for Health the whole-time equivalent staffing levels in an organisation (details supplied) for each year 2020 to date in 2025, broken down by sanctioned posts, filled posts and vacancies, and by division and grade where available; and if she will make a statement on the matter. [74199/25]
View answerI thank the Deputy for his question. My Department has engaged with the Pharmaceutical Society of Ireland (The PSI) and they have submitted the information below in response to your question.
|
- |
Sanctioned Posts |
Filled Posts |
Vacancies |
|
2025 |
58 |
49 |
9 |
|
2024 |
56 |
48.5 |
7.5 |
|
2023 |
56 |
43 |
13 |
|
2022 |
53.61 |
45 |
8.61 |
|
2021 |
52.61 |
43.61 |
9 |
|
2020 |
51.61 |
44.93 |
6.68 |
2132. Deputy Cormac Devlin asked the Minister for Health the details of the PSI’s annual pay and pensions costs; the amount spent on agency staff, contractors and other temporary staffing supports, for each year 2020 to date in 2025; and if she will make a statement on the matter. [74200/25]
View answerI thank the Deputy for his question. My Department has engaged with the Pharmaceutical Society of Ireland (The PSI) and they have submitted the information below in response to your question.
|
YEAR |
Payroll Costs € |
Agency Costs € |
Pension Costs € |
|
2020 |
€3,226,226 |
€621,984 |
€8,954 |
|
2021 |
€3,217,390 |
€523,075 |
€9,015 |
|
2022 |
€3,095,362 |
€660,186 |
€51,853 |
|
2023 |
€3,264,993 |
€613,915 |
€14,174 |
|
2024 |
€3,772,515 |
€529,937 |
€112,813 |
|
Q3 2025 |
€3,444,296 |
€235,932 |
€26,686 |
2133. Deputy Cormac Devlin asked the Minister for Health the PSI’s annual operating budget and outturn; the breakdown of income sources including registration fees and any Exchequer funding, for each year 2020 to date in 2025; and if she will make a statement on the matter. [74201/25]
View answerThe PSI publishes an Annual Report and Financial Statements each year which is available on their website.
(Additional information to follow).
2134. Deputy Cormac Devlin asked the Minister for Health the number of pharmacy inspections carried out by the PSI in each year 2020 to date in 2025, broken down by inspection type including systems inspections, risk-based inspections and re-inspections and by on-site versus remote/desktop inspections where relevant; and if she will make a statement on the matter. [74202/25]
View answerI propose to answer Questions Nos. 2132, 2133 and 2134 together. My Department has engaged with the Pharmaceutical Society of Ireland (The PSI) and they have submitted the information below in response to your question.
The PSI derives its inspection authority from the provisions of Part 7 of the Pharmacy Act, which provides the spectrum and range of actions used for the purposes of ascertaining whether any offence under a relevant enactment, any breach of a code of conduct or any professional misconduct has been committed.
Risk-based inspections are undertaken following a review of information available to the PSI. They may be focused on a particular area or the general operation of the pharmacy, including inspection/compliance history, or where a member of the public or an external body has raised a concern. Risk-based inspections may include systems inspections, focused/thematic inspections or re-inspections to a pharmacy where required.
|
Year |
Total number of inspections |
Risk-based Inspections |
|
|
2020 |
36 |
24 |
All inspections conducted onsite |
|
2021 |
29 |
25 |
All inspections conducted onsite |
|
2022 |
112 |
97 |
3 new opening inspections conducted virtually |
|
2023 |
175 |
143 |
13 new opening inspections conducted virtually |
|
2024 |
365 |
347 |
All inspections conducted onsite |
|
2025 |
328 |
295 |
All onsite except one new opening inspection conducted virtually |
2135. Deputy Cormac Devlin asked the Minister for Health the number of regulatory investigations initiated and concluded by the PSI in each year 2020 to date in 2025; the average and median time to conclusion, and the outcomes recorded including no further action, advice/warning, referral to disciplinary processes and referral to other bodies; and if she will make a statement on the matter. [74203/25]
View answerI thank the Deputy for his question. My Department has engaged with the Pharmaceutical Society of Ireland (The PSI) and they have submitted the information below in response to your question.
|
Year |
Investigations Initiated |
Investigations Concluded |
Average Time to Conclusion* (Days) |
Median Time to Conclusion* (Days |
Formal Complaints |
No Further Action |
Other Actions** |
|
2020 |
7 |
8 |
772 |
717 |
10 |
3 |
6 |
|
2021 |
10 |
7 |
525 |
151 |
4 |
0 |
4 |
|
2022 |
6 |
8 |
404 |
638 |
8 |
0 |
11 |
|
2023 |
9 |
8 |
343 |
133 |
5 |
1 |
2 |
|
2024 |
7 |
7 |
386 |
293 |
2 |
4 |
2 |
|
2025 |
8 |
6 |
694 |
683 |
2 |
3 |
1
|
*considered by the Registrar under Section 71 of the Pharmacy Act 2007
**Actions taken by the Registrar under Section 71(1)(d) of the Pharmacy Act 2007 include for example, a re-inspection, request voluntary undertakings, meeting with those in governance positions, refer an authorised officer’s report to another body, initiate summary legal proceedings / prosecution, request the Council of the Pharmaceutical Society of Ireland (PSI) to formally consider making an application to the High Court seeking an Order pursuant to section 45 of the Pharmacy Act 2007 suspending a pharmacist’s or a pharmacy’s registration pending further procedures under Part 6 the Pharmacy Act 2007
2136. Deputy Cormac Devlin asked the Minister for Health the number of complaints received by the PSI; the number progressed to preliminary proceedings; the number progressed to formal inquiry; the number resulting in sanctions, broken down by sanction type including admonishment, conditions, suspension and cancellation; whether the sanction related to an individual pharmacist or a retail pharmacy business for each year 2020 to date in 2025; and if she will make a statement on the matter. [74204/25]
View answerI would like to thank the Deputy for the Parliamentary Question, my officials have reached out to the Pharmaceutical Society of Ireland (PSI) directly and they have provided the following information which I hope you will find useful.
The table below sets out the number of statutory complaints received by the PSI for the years 2020-2025, as well as the number of complaints considered by the Preliminary Proceedings Committee (PPC) and the number of complaints the PPC referred forward for to the PSI’s Committees of Inquiry (Professional Conduct Committee and Health Committee).
|
Year |
2020 |
2021 |
2022 |
2023 |
2024 |
2025 |
|
Complaints Received |
46 |
80 |
53 |
73 |
78 |
48 |
|
Considered by PPC |
37 |
59 |
58 |
77 |
50 |
89 |
|
Referred to Inquiry |
15 |
25 |
13 |
29 |
11 |
34 |
Note: Statutory complaints considered by the PPC in a calendar year may have been received by the PSI in a previous year.
Sanctions imposed by Council (and subsequently confirmed by the High Court where necessary) for each year, 2020-2025.
2020
|
Sanction type |
Censure |
Conditions |
|
Number |
4 |
4 |
*All of the above sanctions were imposed as against individual pharmacists.
2021
|
Sanction type |
Censure/Admonishment |
Cancellation |
Conditions |
|
Number |
4 |
1 |
2 |
*All of the above sanctions were imposed as against individual pharmacists.
2022
|
Sanction type |
Censure/Admonishment |
Cancellation |
Conditions |
|
Number |
11 |
2 (1 with a prohibition on restoration to the PSI register). |
2
|
*Conditions were imposed as against one retail pharmacy business. The remainder of the sanctions were imposed against individual pharmacists.
2023
|
Sanction type |
Censure/Admonishment |
Cancellation |
Conditions |
Suspension |
|
Number |
13 |
3 |
2 |
2 |
*The sanction of cancellation was imposed as against one retail pharmacy business. The remainder of the sanctions were imposed against individual pharmacies.
2024
|
Sanction type |
Censure/Admonishment |
Cancellation |
Conditions |
Suspension |
|
Number |
7 |
2 |
4 |
2
|
*The sanctions of censure and conditions were imposed on one retail pharmacy business.
The sanctions of suspension and conditions were imposed on one retail pharmacy business.
The remainder of the sanctions were imposed against individual pharmacies.
2025
|
Sanction type |
Censure/Admonishment |
Cancellation |
Conditions |
|
Number |
4 |
2 (1 with a prohibition on restoration to the PSI register) |
2 |
*All of the above sanctions were imposed as against individual pharmacists.
2137. Deputy Cormac Devlin asked the Minister for Health the PSI’s enforcement actions other than fitness-to-practise sanctions; the number of warning/advisory letters, undertakings, any District Court proceedings, and any other formal compliance actions; and the basis on which such actions are deployed for each year 2020 to date in 2025; and if she will make a statement on the matter. [74205/25]
View answerI thank the Deputy for the question. My Department has engaged with the Pharmaceutical Society of Ireland (PSI) and they have submitted the information below in response to the question.
The Registrar considers significant issues identified during an inspection or an investigation under Section 71 of the Pharmacy Act 2007. This is a function designated to the Registrar by the Council. The Registrar has a number of options available including; to take no action [under Section 71(1)(a)], to commence disciplinary proceedings/make a formal complaint [under Section 71(1)(b)], or to take such other actions [under Section 71(1)(d)] as the Registrar considers appropriate in the circumstances.
The number of actions/decisions taken by the Registrar under Section 71 of the Act are reported in the PSI's annual report. In 2020, the Registrar exercised the legislative authority on a total of 13 occasions, 7 in 2021, 11 in 2022, 2 in 2023, 2 in 2024 and 1 in 2025.
Actions taken by the Registrar under Section 71(1)(d) of the Pharmacy Act 2007 include but are not limited to re-inspection, requesting voluntary undertakings, enforcement letters, meeting with those in governance positions, referring an authorised officer’s report to another body, initiating summary legal proceedings/prosecution, or requesting the Council of the PSI to formally consider making an application to the High Court seeking an Order pursuant to section 45 of the Pharmacy Act 2007 suspending a pharmacist’s or a pharmacy’s registration pending further procedures under Part 6 the Pharmacy Act 2007.
2138. Deputy Cormac Devlin asked the Minister for Health the number of complaints received by the PSI in each year 2020 to date in 2025, relating specifically to patient access and communications including inability to contact a pharmacy by phone, delayed responses to patient queries, or failures in continuity of supply communications; and the outcomes of such complaints including inspection triggered, advice issued, enforcement action taken and no further action; and if she will make a statement on the matter. [74206/25]
View answerI thank the Deputy for his question. My Department has engaged with the Pharmaceutical Society of Ireland (The PSI) and they have submitted the information below in response to the question.
The following answer interprets the use of the word “complaints” (as per the question) as meaning “complaint” pursuant to section 33 of the Pharmacy Act 2007 (‘the Act’), i.e. statutory complaints and the process relevant to same under Part 6 of the Act.
The PSI categorises statutory complaints received into a number of sub-categories. By way of example, these sub-categories include the following (please note this is not an exhaustive list):
Behaviour.
Dispensing Error.
Emergency supply issues.
Failure to supply.
Health impairment.
Out of date medication.
Having reviewed the question to hand, the PSI’s view is that the sub-category most closely aligning to same is ‘Behaviour’.
Please see the table below setting out the statistics relevant to this category for the years 2020-2025:
|
Year |
2020 |
2021 |
2022 |
2023 |
2024 |
2025 |
|
No. complaints |
8 |
11 |
11 |
9 |
21 |
21 |
It is noteworthy that some complaints may fall into multiple sub-categories. For example, an individual complaint may contain multiple allegations around behaviour as well as a dispensing error(s), for instance.
In the context of the statutory complaints process as contained under Part 6 of the Act, “inspections triggered/advice issued/enforcement action taken” do not arise.
Insofar as “no further action” is concerned, all statutory complaints received by the PSI must follow the statutory complaints process as set out under Part 6 of the Act. Accordingly, any complaints received by the PSI against registrants will proceed to the Preliminary Proceedings Committee (PPC) for its consideration.
The table below sets out the PPC’s decision-making with regard to “no further action” regarding statutory complaints received.
|
Year |
2020 |
2021 |
2022 |
2023 |
2024 |
2025 |
|
No. of complaints considered by PPC |
37 |
59 |
58 |
77 |
50 |
89 |
|
No further action |
12 |
28 |
40 |
36 |
32 |
52 |
2139. Deputy Cormac Devlin asked the Minister for Health the standards, guidance or policies the PSI has issued to pharmacies and pharmacists regarding communications with patients including responsiveness, accessibility, and the handling of urgent clinical queries; if the PSI sets or expects any minimum operational arrangements including phone access, voicemail, email or other channels to protect patient safety; and if she will make a statement on the matter. [74207/25]
View answerI would like to thank the Deputy for the Parliamentary question, for which I requested information from the Pharmaceutical Society of Ireland (PSI) directly. I hope the below information is useful to the Deputy.
The PSI has not issued any specific guidance for pharmacies regarding responsiveness, accessibility, and the handling of urgent clinical queries.
The PSI has issued Guidelines to support Medicines Therapy Review, Counselling, and Prescription Extension, which provide a principles-based outline of the responsibilities of all registered pharmacists, including those in pharmacy governance roles, regarding medicine therapy (Clinical) review, patient counselling and extending the validity of prescriptions.
In relation to the minimum operational arrangements including phone access, voicemail, email or other channels to protect patient safety, the PSI Guidelines on the Equipment Requirements of a Retail Pharmacy Business require pharmacies to have a direct dedicated telephone line, internet and email access, as well as a fax machine.
2140. Deputy Cormac Devlin asked the Minister for Health the oversight arrangements and performance indicators in place between her Department and the PSI; the targets or expectations in respect of inspection volumes, complaint handling timelines, and public accessibility/communications safeguards; to outline any reviews, audits or improvement plans agreed since 2020, including any planned measures for 2026; and if she will make a statement on the matter. [74208/25]
View answerThe Pharmaceutical Society of Ireland (PSI) is a statutory body, independent in the exercise of its functions, which was established under the Pharmacy Act 2007 (referred to hereafter as ‘the Act’). The legislative framework through which the PSI operates is the Act and the Regulations made under it. The Society functions as an independent State body under the aegis of the Department of Health (DoH) in accordance with its statutory role as per the provisions of the Act. As a State body, the Society aims to fully comply with its legal obligations under the Ethics in Public Office Act, the Freedom of Information Act, the General Data Protection Regulation, Protected Disclosures Legislation, Irish and EU procurement regulations, and public pay policy.
Oversight of the PSI is governed through formal Oversight Agreements (OA) and Performance Delivery Agreements (PDA) in place for the period 2020–2026, which set out agreed levels of service and performance between the PSI and the Minister for Health/Department of Health. These agreements align with the PSI’s Corporate Strategy and the Department’s Statement of Strategy.
In accordance with the OA/PDA, the Department and the PSI engage through:
• Formal governance meetings at least three times per year, at which performance, governance, risk, and compliance matters are reviewed.
• Annual submission of the PSI’s Annual Report and Financial Statements
The PSI Council, a 21-member board with a lay majority appointed by the Minister, provides strategic leadership and ensures the PSI fulfils its statutory functions.
Performance Indicators in Place
The Oversight and Performance Delivery Agreements form part of the agenda of the governance meetings between the PSI and the Department of Health, where the Society’s performance and compliance with the Code of Practice for the Governance of State Bodies 2016, as amended, are reviewed.
Performance is assessed against the deliverables and key performance indicators set out in the PSI's annual service plan and the Performance Delivery Agreements, with due regard to the PSI’s statutory role.
Key outputs are defined in the PSI’s Corporate Strategies. Progress on agreed corporate and annual service plan objectives is monitored by the PSI Executive Leadership Team, with oversight by the PSI Council and its Committees. This includes both quantitative metrics—such as inspection volumes, budgeting and expenditure, complaint processing timelines, and FMD compliance rates—and qualitative measures outlined in the DoH–PSI Oversight Agreement. The Department reviews these indicators at the governance meetings.
The PSI has multiple measures in place to support accessibility, transparency, and effective public communication, including:
• A public-facing website providing up-to-date regulatory information, the public register of pharmacists and pharmacies, and accessible instructions on how to raise concerns or make a statutory complaint.
• Maintaining responsive communication channels (phone, email, online services) to support the diverse needs of the public.
• Commitment to accessibility and inclusivity initiatives, ensuring that PSI information and services are accessible to people with disabilities or additional needs.
• These measures complement the PSI’s broader regulatory function to protect the health, safety and wellbeing of the public.
Reviews, Audits and Improvement Plans Since 2020
Between 2020 and 2026, the PSI has undertaken performance review activities, including:
• Annual internal audits, external audit processes, and governance reviews overseen by the Audit & Risk Committee.
• Continuous review and enhancement of internal control systems, including financial, operational and compliance controls, as required under the Code of Practice.
• Ongoing oversight of risk management systems, with quarterly reviews by the Audit & Risk Committee and Council. Risk is a standing agenda item as part of the formal governance meetings.
• Publication of Annual Reports and Financial Statements each year, outlining progress against strategic and service plan objectives.
These reviews ensure that the PSI’s regulatory activities remain robust, proportionate, and aligned with public-health priorities.
Planned Measures for 2026
In 2026, the PSI will continue implementation of its Corporate Strategy 2025–2028, with a focus on delivering the strategic activities, core regulatory functions and organisational development actions set out in both the 2026 Service Plan and the PSI–DoH Oversight and Performance Delivery Agreements. Key areas of work for 2026 will include:
• Strengthening inspection, enforcement, and complaints management systems, including updating the Inspection and Enforcement Policy, implementing a more risk-based, intelligence-driven regulatory approach, advancing reforms to fitness-to-practice processes, and supporting expanded models of pharmacy practice.
• Supporting the development and delivery of an effective regulatory framework aligned with national policy, including contributions to the implementation of the Community Pharmacy Agreement 2025, the rollout of expanded pharmacist services (Common Conditions Service, contraception continuation, future autonomous prescribing), and progressing the reform of the Pharmacy Act in collaboration with the Department of Health.
• Expanding capacity to support enhanced pharmacy services, including delivering training and regulatory supports for expanded scope-of-practice initiatives, enhancing CPD systems for pharmacists and pharmaceutical assistants, and ongoing work under the Workforce Intelligence Report to support strategic workforce planning.
• Maintaining strong governance, risk management, financial oversight, and compliance structures under the Oversight Agreement/Performance Delivery Agreement, including continued implementation of the Strategic Workforce Review, delivery of internal audit and risk management commitments, and ensuring compliance with the Code of Practice for the Governance of State Bodies.
As part of its Governance Function and in line with the requirement under the [Code of Practice for the Governance of State Bodies] the Department of Health will undertake a Periodic Critical Review (PCR) of the PSI during 2026/27. Periodic reviews provide assurance and challenge about the continuing need, efficiency and good governance of public bodies, and are part of a wider strategy for Government expenditure, to ensure that it is targeted, subject to evaluation and delivering against its original objectives.
2141. Deputy Michael Cahill asked the Minister for Health to urgently intervene and allow for a transitional payment in the case of a person (details supplied); and if she will make a statement on the matter. [74230/25]
View answerAs this is an operational matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
2143. Deputy Conor D. McGuinness asked the Minister for Health if her Department is examining the expansion of the approved appliances and drugs under the long-term illness scheme in light of ongoing difficulties with the approval request process for pharmacies; the impact these difficulties are having on people with disabilities and other long-term illness card holders who are being required to pay upfront for necessary prescribed items; and if she will make a statement on the matter. [74232/25]
View answerThe Health Service Executive (HSE) has responsibility for pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. Therefore, I have asked the HSE to respond to the Deputy directly, as soon as possible.
2144. Deputy Mark Wall asked the Minister for Health when the endometriosis hub in Cork will be fully staffed, to provide a breakdown of how many people have accessed the hub in 2025, in tabular form; and if she will make a statement on the matter. [74244/25]
View answerAs this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
